May 2012
By Bill Lydon – Editor
This article on maintaining documentation for the life cycle of installed automation and control systems in pharmaceutical plants is the fourth article in a series covering the recent annual Pharmaceutical Automation Roundtable (PAR).
I had the privilege of attending the Pharmaceutical Automation Roundtable as an observer in November 2011. This PAR was hosted by Johnson & Johnson in Spring House, PA, with Dave Stauffer, Terry Murphy, and Joel Hanson of Johnson & Johnson participating.
Lead automation engineers from various parts of the world attended the invitation-only, two-day event. This is the most knowledgeable group of automation professionals gathered in one place at any one time focused on discussing automation issues. A range of companies participated including Abbott, Amgen, Biogen Idec, BMS, Genentech, Genzyme, Glaxo, Imclone, Johnson & Johnson, Eli Lilly, Lonza, NNE Pharmaplan, Novo Nordisk, Pfizer, and Sanofi-Aventis.
The PAR was founded about 15 years ago by Dave Adler and John Krenzke, both with Eli Lilly and Company at the time, as a means of benchmarking and sharing best practices for automation groups among peer pharmaceutical companies. The group specifically does not discuss confidential or proprietary information, cost or price of products, price or other terms of supply contracts, or plans to do business or not do business with specific suppliers, contractors, or other companies.
The individual PAR group members have a wealth of practical knowledge and knowhow to share with other participants, truly learning from each other.
Topics are agreed upon prior to the meeting and a member with make a presentation on their organizations views and approach to the topic. After this presentation others comment on their organizations situation.
The PAR presenter discussed the significant amount of details created, defined, and communicated during the construction of a facility resulting in a large amount of information and documentation. Some of this information should be kept current throughout the facility’s lifecycle which could be a long time (i.e.: 30+ years). The question is how much of the information created should be maintained as accurate during the life cycle of the automation and control system?
Reasons for maintaining the information include product safety, personnel safety, facility safety, and regulatory requirements (FDA, EPA, OSHA, etc.) Having the appropriate documentation can also save time and money when doing upgrades and changing products produced in a facility which is happening ever more frequently.
Various groups create and maintain information including process flow diagrams, equipment flow diagrams, piping and instrument diagrams, and facility design. Information from the automation and instrumentation group includes automation system hardware design, logical design, systems architecture, network design details, instrument specifications, instrument installation details ( i.e. mounting), instrument wiring details (including packaged equipment), hardwired interlock and safety circuit details, power wiring details, and cabinet layouts.
The automation software design is another major amount of information including functional requirements/specifications, software interlocks, control loops, equipment and control modules, batch recipes & phase designs, software design details, and controller application code.
Information can be presented in many ways including manual drawings, CAD drawings, electronic models, commercial engineering software formats, un-contextualized text (Word documents), contextualized text (e.g. custom databases).
The following items are based on the discussion by PAR members on this topic. Defining the value of investments in creating and maintaining documentation over the lifecycle is becoming clearer. Accurate data can save money on audits, maintenance, renovations, modernizations, multi-product production conversions, optimizations, troubleshooting, problem investigations, and disaster recovery.
The experience of most participants illustrates that efficient commercial software offerings do not exist to meet their documentation requirements. The documentation of legacy operations is difficult since much of the information is not in digital form and in many companies the documentation over time on these sites is not kept up to date. However, when upgrades and retrofits are done on existing sites, that documentation is done.
Participants had various methods for document management as illustrated by these participant comments:
Editor’s note:It was noted that most engineering firms have created their own software and some users have done the same. One user commented they are finding custom created databases are much more efficient for documentation.
Packaged and skid equipment continues to be a challenge, including documentation. It seems a major issue is getting this equipment specified properly and then enforcing the specifications in the purchase process.
PAR Participant comments:
These comments from participants will give an idea of current operating standards and policies. It makes sense that using plants for multiple products, flexible manufacturing, requires accurate up to date documentation.
PAR participant comments:
The discussion on documentation reminded me of the BIM (Building Information Modeling) trend that started in the 1980s in the commercial buildings industry. BIM is a process involving the generation and management of a digital representation of physical and functional characteristics of a facility. The resulting building information model becomes a shared knowledge resource to support decision-making about a facility from earliest conceptual stages, through design and construction, then through its operational life before its eventual demolition. BIM has taken years to evolve and only recently are information standards starting to come into focus, allowing BIM to be practical. BIM requires vendors to provide detailed information in open digital form, typically XML.
Biopharmaceutical plants are far more complex so an effort similar to BIM might be monumental and it is unclear what body or organization would be the focal point for this holistic effort.
It is interesting that the experience of most participants illustrates that efficient commercial software offerings do not exist to meet their documentation requirements.
Your thoughts and comments are welcomed.
